The present invention relates in general to disposable cartridges for surgical instruments and in particular to a new and useful disposable cartridge and method for manufacturing the cartridge for use in a surgical instrument.
It is a well established practice in the surgical field to utilize surgical instruments for either transecting, fastening or providing hemostasis to tissue, vessels or organs (hereinafter "tissue"). In order to achieve these desired therapeutic effects, it is common practice for a surgeon to utilize a surgical fastening instrument that includes a cartridge containing a plurality of fasteners or clips. Since there are a number of surgical procedures that require multiple firings from a particular surgical fastening instrument, it is common to utilize a cartridge that is disposable such that once the instrument is fired, the cartridge is removed from the instrument and a new cartridge is loaded in its place.
Typically, a disposable fastener cartridge is used in surgical tissue fastening instruments that position the disposable cartridge in an opposed space relationship to an anvil. The anvil provides a fastener forming surface for forming the fired staples or clips thereagainst. In order to achieve the desired therapeutic effects outlined above, tissue is positioned between the cartridge and the anvil of the surgical fastening instrument. These instruments also include a driver assembly that actuates the cartridge for ejecting the fasteners through the tissue for being formed against the anvil.
U.S. Pat. No. 4,633,874 (Chow et al.) discloses a typical surgical fastening instrument which utilizes a disposable fastener cartridge. This instrument is a linear cutter which is generally used in open surgical procedures and includes a disposable cartridge and an anvil. As mentioned above, tissue is placed between the cartridge and the anvil of the linear cutter prior to firing. Upon firing of the cutter, a series of staple rows are formed in the tissue while a cutting knife is advanced between the staple rows for transecting the captured tissue. The cartridge utilized in this type of linear cutter is disposed of once the instrument is fired.
U.S. Pat. No. 5,332,142 (Robinson et al.) discloses a linear cutter which is used for endoscopic surgical procedures. This type of linear cutter is similar to the linear cutter outlined above, however, both the cartridge and the anvil are located at the distal end of an elongated shaft for facilitating tissue fastening and transection in various minimally invasive surgical procedures.
U.S. Pat. No. 4,527,724 (Chow et al.) discloses a linear stapler that is used in open surgical procedures. This type of linear stapler also includes a disposable fastener cartridge and an anvil positioned directly opposite the cartridge. Once tissue has been positioned between the cartridge and the anvil, the cartridge is movably adjusted with respect to the anvil for adjusting the gap between the cartridge and the anvil. Once this instrument is fired, a cutting instrument such as a scalpel may be required to transect the fastened tissue if so desired. This transection occurs by advancing the scalpel blade across the tissue and against the anvil.
All of the instruments referenced above, are utilized in various surgical procedures that may require multiple firings of the instrument. Accordingly, all of these instruments utilize a disposable cartridge having a plurality of fasteners, staples or clips that are stored within the cartridge and deployed from the cartridge upon firing of the instrument. It is greatly appreciated by those of ordinary skill in the surgical field that these cartridges are required to be quite sophisticated in design and construction in order to meet the demanding precisional requirements of the various surgical procedures. It is critical that a disposable fastener cartridge be designed and constructed such that upon firing, the cartridge ejects fasteners that exhibit expected and predicted fastener heights when fired into tissue. Accordingly, it is extremely important that the cartridge exhibit repeatable and predicable performance.
Thus, great care is taken in the design and manufacture of disposable cartridges. Due to the sophistication of the cartridge design, the manufacturing process for these cartridges can be quite rigorous due to the various manufacturing steps that are required. These steps are required to be carried out with great precision and care in order to ensure the quality that is expected from the surgeon and the patient. Accordingly, rigorous specifications are required for both the cartridges design and manufacture in order to prevent misfires, defective deployment of fasteners or jamming of the surgical instrument upon firing. Thus, significant effort and process controls are put into place to ensure that cartridges meet these specifications. As one could imagine, a great deal of resources are required in order to deliver a high quality disposable cartridge.
In a surgical environment in which cost is an extremely important factor, it is imperative that the disposable cartridges have a design and method for manufacturing that is cost effective yet be able to meet rigorous specification requirements. Presently, there is no known surgical fastener cartridge that has a design that supports an efficient and cost effective manufacturing process and that sufficiently meets the precision and quality requirements for use in surgery.